Treatment for Prevention of COVID-19 Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of Comirnaty in Individuals 16 and Older New Phase 3 data show booster (third) dose of Comirnaty induces significant SARS-CoV-2 neutralizing antibody titers and demonstrated a favorable safety and tolerability profile SARS-CoV-2 neutralizing
Month: August 2021
ATLANTA, Aug. 30, 2021 /PRNewswire/ — UCB announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Briviact (brivaracetam) CV tablets, oral solution, and injection to treat partial-onset seizures in patients as young as one month of age.2 This is the first time that the IV formulation of Briviact
August 30, 2021 Audience: Health Professional, Pharmacy August 30, 2021 – Teligent Pharma, Inc. is voluntarily recalling one lot of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle to the user level. The product is being recalled because the firms testing has found it to be super potent based on an
GAITHERSBURG, Md., Aug. 30, 2021. Novavax, Inc. , a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Centers for Disease Control and Prevention (CDC) has provided updated guidance for those who have been vaccinated as part of a clinical trial in the U.S. The CDC guidance states that participants
Please be advised that this video contains graphic footage of surgery. This video demonstrates a level II-IV select neck dissection (cervical lymphadenectomy) performed and narrated by Dr. Kathryn Van Abel. Series Editors: Andrew J. Goates, M.D.; Cynthia M. Chweya, B.S.; Matthew L. Carlson, M.D. To learn more about the Department of Otorhinolaryngology at Mayo Clinic,
What is it that makes a simple jigsaw puzzle such an effective mindfulness practice? It’s the rainy day classic that became a lockdown essential, and while there’s nothing new about puzzles (the first jigsaw is thought to have been created in 1762), many of us are just starting to realise the potentially mindful boost that
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Patients on immunosuppressive or immunomodulatory therapy should receive a third dose of either the Pfizer-BioNTech COVID-19 vaccine or the Moderna COVID-19 vaccine at least 28 days after the second dose of either of these two mRNA vaccines, according to updated recommendations
Taiwan is banking on a homegrown Covid-19 shot to speed up its inoculation program as the island and many countries struggle to secure vaccine deliveries from major drug companies. The locally produced Covid vaccine from Medigen Vaccine Biologics was rolled out last week, with President Tsai Ing-wen receiving her first shot of the two-dose vaccine
Since the COVID-19 pandemic reached the United States in early 2020, scientists have struggled to find laboratory models of SARS-CoV-2 infection, the respiratory virus that causes COVID-19. Animal models fell short; attempts to grow adult human lungs have historically failed because not all of the cell types survived. Undaunted, stem cell scientists, cell biologists, infectious
As we get older, it’s more and more likely that more of us will live alone. According to the latest information from the Merck Manuals, some 28% (14.7 million) of US community-dwelling older adults live alone (21% of older men and 34% of older women). The numbers increase with age – some 44 percent of
Public health authorities have been persuading the general masses to get the COVID-19 booster shots once they have become available. But the guidance has mostly been for those who received the mRNA vaccines from Pfizer and Moderna, leaving recipients of Johnson & Johnson’s Janssen vaccine wondering if they also need the additional dose of the vaccine.
A new study from Africa shows a remarkable 70% reduction in malaria if two treatments — a vaccine and an antimalarial medication — are combined instead of giving them individually. Malaria is endemic in the tropics. The World Health Organization (WHO) reports that in 2019, there were 229 million cases and 409,000 deaths from this
A risk-based booster dose strategy for COVID-19 vaccines could target populations at risk of severe disease and those critical to the public health infrastructure, CDC staff said at a meeting of CDC’s Advisory Committee on Immunization Practices (ACIP) on Monday. Though FDA has yet to review data on booster doses for COVID-19 vaccines among the
elamipretide Treatment for Barth Syndrome Stealth BioTherapeutics Submits Elamipretide New Drug Application to FDA for Treatment of Barth Syndrome BOSTON, Aug. 24, 2021 /PRNewswire/ – Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced the submission of a New Drug Application (NDA)
PRINCETON, N.J.–(BUSINESS WIRE) August 20, 2021 — Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 240 mg every two weeks or 480 mg every four weeks (injection for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at
Carotid artery surgery and stenting have comparable long-term effects on fatal or disabling stroke in asymptomatic patients with severe carotid artery stenosis. That’s the finding of late breaking research presented in a Hot Line session today at ESC Congress 2021 and published simultaneously in The Lancet. Patients with severe carotid artery stenosis are at elevated
This year marks the 20th anniversary of International Overdose Awareness Day. Since it started in 2001, it served as a way for governments and special organizations to help reduce the stigma towards drug and overdose victims. A Global Crisis Overdose (OD) is described as taking too much of a substance, in this case, drugs, that it becomes
A new noninvasive procedure is safe and effective for treating patients with mild Alzheimer’s disease (AD), new research suggests. The approach uses MRI-guided low-intensity focused ultrasound (FUS) and injected microbubbles to temporarily open the blood-brain barrier (BBB). In a small group of patients, the procedure was significantly associated with reduced amyloid plaque and cognitive decline.
Pulp is the soft mass of connective tissue that is located in the center of the tooth. Dental pulp also contains nerves and blood vessels to provide essential nutrients to keep the tooth healthy and working properly. A pulpectomy is the removal of pulp tissue from all parts of a tooth that has become irreversibly
An Israeli man receives a third shot of coronavirus disease (COVID-19) vaccine as country launches booster shots for over 30-year-olds, in Rishon Lezion, Israel August 24, 2021. Nir Elias | Reuters Israeli lawmakers are keen to avoid another lockdown after overseeing one of the world’s fastest vaccination drives. New daily coronavirus infections, however, have just
A deep look into a nationwide mass vaccination setting in Israel revealed that the BNT162b2 (Pfizer–BioNTech) vaccine is not linked with an elevated risk of a majority of the adverse events under study, with the exception of myocarditis. However, even that potentially severe adverse event is much more pervasive following the infection with severe acute
In patients with coronary artery disease scheduled for a percutaneous intervention (PCI), fractional flow reserve (FFR) assessment at the time of angiography significantly improves outcome, but it has no apparent value as a routine study in all CAD patients, according to the randomized RIPCORD 2 trial. When compared to angiography alone in an all comer-strategy,
Finerenone (Kerendia) prevents cardiovascular (CV) and some renal events in type 2 diabetes patients with earlier stages of kidney disease, the FIGARO-DKD trial showed. In the trial’s stage 1 to 4 kidney disease patients with moderate-to-severe albuminuria, the nonsteroidal mineralocorticoid receptor antagonist (MRA) reduced the composite of CV death, nonfatal myocardial infarction or stroke, or
ABBOTT PARK, Ill., Aug. 27, 2021. Abbott today announced results of the landmark GUIDE-HF clinical trial, a 1,000 patient randomized study designed to assess the benefits of the CardioMEMS HF System in people living with NYHA Class II, III and IV heart failure. Data adjusted for the impact of COVID-19 show a strong reduction in
Family bonds often run the deepest, which is why it’s all the more painful when they break down. Here, with the help of a counsellor, we explore how to navigate difficult family relationships Families: they’re not always easy. Separation, blended households, addictions, mental illness, money problems, betrayal, expectations, communication, or simply clashing personalities – there
Remember when your mom made sure you wash your face every day when you were younger? Well, she’s right. Having a regular skincare routine is crucial in maintaining healthy, radiant skin. So, are you using one of the best facial cleansers yet? Why You Need a Facial Cleanser Never skip facial cleansers in your routine
The addition of image-guided atrial fibrosis ablation did not significantly reduce the risk of recurrence relative to pulmonary vein isolation (PVI) alone in patients with treatment-resistant atrial fibrillation (AFib), according to results of an intention-to-treat analysis of the randomized DECAAF II trial. However, there was a significant advantage for the addition of image-guided ablation in
Elizabeth Holmes, founder and former CEO of Theranos, arrives for motion hearing on Monday, Nov. 4, 2019, at the U.S. District Court House inside Robert F. Peckham Federal Building in San Jose, California. Yichuan Cao | NurPhoto | Getty Images In a bombshell revelation just days before her criminal fraud trial, defense attorneys for Elizabeth
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